Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: RoActemra   
Auth. number : EU/1/08/492
INN : tocilizumab
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L04 - Immunosuppressive agents
Pharmacological subgroup: L04A - Immunosuppressive agents
Chemical subgroup: L04AC - Interleukin inhibitors
Chemical substance: L04AC07 - Tocilizumab
(See WHO ATC Index)
Indication: RoActemra, in combination with methotrexate (MTX), is indicated for:
• the treatment of severe, active and progressive rheumatoid arthritis (RA) in adults not
previously treated with MTX.
• the treatment of moderate to severe active RA in adult patients who have either responded
inadequately to, or who were intolerant to, previous therapy with one or more diseasemodifying
anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) antagonists.

In these patients, RoActemra can be given as monotherapy in case of intolerance to MTX or where
continued treatment with MTX is inappropriate.
RoActemra has been shown to reduce the rate of progression of joint damage as measured by X-ray
and to improve physical function when given in combination with methotrexate.

RoActemra is indicated for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in
patients 2 years of age and older, who have responded inadequately to previous therapy with NSAIDs
and systemic corticosteroids. RoActemra can be given as monotherapy (in case of intolerance to MTX
or where treatment with MTX is inappropriate) or in combination with MTX.

RoActemra in combination with methotrexate (MTX) is indicated for the treatment of juvenile
idiopathic polyarthritis (pJIA; rheumatoid factor positive or negative and extended oligoarthritis) in
patients 2 years of age and older, who have responded inadequately to previous therapy with MTX.

RoActemra can be given as monotherapy in case of intolerance to MTX or where continued treatment
with MTX is inappropriate.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

 

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/01/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/955 (2009)233 of 16/01/2009
20/01/2009 Centralised - Authorisation EMEA/H/C/955 (2009)232 of 16/01/2009
15/04/2009 Centralised - Variation EMEA/H/C/955/IB/1
29/09/2009 Centralised - Variation EMEA/H/C/955/II/2
30/10/2009 Centralised - Variation EMEA/H/C/955/II/3, 4 (2009)8508 of 28/10/2009
12/11/2009 Centralised - Variation EMEA/H/C/955/II/6
24/11/2009 Centralised - Variation EMEA/H/C/955/II/5 (2009)9346 of 20/11/2009
29/03/2010 Centralised - Variation EMEA/H/C/955/II/12
29/03/2010 Centralised - Variation EMEA/H/C/955/II/11
01/04/2010 Centralised - Variation EMEA/H/C/955/II/8, 9 (2010)2271 of 30/03/2010
29/04/2010 Centralised - Variation EMEA/H/C/955/II/10 (2010)2847 of 27/04/2010
08/06/2010 Centralised - Variation EMEA/H/C/955/II/7 (2010)3708 of 04/06/2010
23/12/2010 Centralised - Variation EMEA/H/C/955/II/14 (2010)9650 of 20/12/2010
31/01/2011 Centralised - Variation EMEA/H/C/955/II/16/G
23/03/2011 Centralised - Variation EMEA/H/C/955/II/13 (2011)1933 of 18/03/2011
02/08/2011 Centralised - Variation EMEA/H/C/955/II/15 (2011)5697 of 01/08/2011
03/08/2011 Centralised - Variation EMEA/H/C/955/II/15 (2011)5696 of 01/08/2011
26/09/2011 Centralised - Variation EMEA/H/C/955/II/15 (2011)6938 of 22/09/2011
31/05/2012 Centralised - Variation EMEA/H/C/955/II/22 (2012)3585 of 25/05/2012
28/06/2012 Centralised - Variation EMEA/H/C/955/IB/23
Updated with Decision(2012)8707 of 22/11/2012
03/12/2012 Centralised - Variation EMEA/H/C/955/II/27 (2012)8707 of 22/11/2012
13/12/2012 Centralised - Variation EMEA/H/C/955/II/28
Updated with Decision(2013)3378 of 30/05/2013
03/06/2013 Centralised - Variation EMEA/H/C/955/II/26 (2013)3378 of 30/05/2013
30/09/2013 Centralised - Renewal EMEA/H/C/955/R/31 (2013)6349 of 25/09/2013
23/01/2014 Centralised - Variation EMEA/H/C/955/II/35
28/04/2014 Centralised - Variation EMEA/H/C/955/X/30 (2014)2828 of 23/04/2014
24/07/2014 Centralised - Variation EMEA/H/C/955/II/39
30/07/2014 Centralised - Variation EMEA/H/C/955/IB/40